Prostate Cancer research study

What is the primary objective of this study?

The purpose of this study is to find out if giving Reolysin in combination with docetaxel and
prednisone can offer better results than standard therapy with docetaxel and prednisone.

Who is eligible to participate?

Inclusion Criteria:
- Patients must have a histological diagnosis of adenocarcinoma of the prostate.
- All patients must have a formalin fixed paraffin embedded tissue block (from their
primary or metastatic tumour) available for translational studies.
- Presence of clinically and/or radiologically documented disease (measurable or
non-measurable). All radiology studies must be performed within 28 days prior to
randomization (within 35 days if negative). Patients with elevated PSA only are not
eligible.
- Androgen ablation must include either medical or surgical castration. If the patient
is receiving medical androgen ablation, a castrate level of testosterone (< 1.7
nmol/L) must be present.
- Patients must have metastatic or locally recurrent disease, for which no curative
therapy exists and for which systemic therapy is indicated due to progression
following castration.
Progression is defined as one or both of the following:
PSA Progression:
A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a
reference value (not necessarily consecutively), measured a minimum of one week apart. The
PSA that confirms progression must have a value of ≥2 ng/ml and must be performed no longer
than 7 days prior to trial randomization. Patients who have had prolonged responses to
combined androgen blockade should be evaluated for a withdrawal response prior to
confirming eligibility OR
Radiological Progression:
defined as the development of new metastatic lesions or progression in target disease
(RECIST 1.1) with a stable or rising PSA.
- The PSA must be ≥ 5 ng/ml at the time of study entry.
- ECOG performance of 0, 1 or 2.
- Age ≥ 18 years of age.
- Patients must have a life expectancy of ≥ 12 weeks.
- Previous Therapy
Surgery:
Previous major surgery is permitted provided that it has been at least 14 days prior to
patient randomization and that wound healing has occurred.
Chemotherapy:
Patients may NOT have received any prior cytotoxic chemotherapy for recurrent/metastatic
castration resistant prostate cancer. Prior docetaxel treatment is not permitted unless it
was provided on an adjuvant therapy protocol more than 12 months prior to study enrollment.
Hormonal Therapy:
Prior hormone therapy is required. Patients must be castrate resistant and have
discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for
bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients
already receiving this treatment at the time of enrollment. If the patient has discontinued
the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate
level of testosterone must be present. Prior therapy with CYP17 inhibitors (e.g.
abiraterone, ketoconazole) or novel anti-androgens (e.g. MDV3100) is permitted.
Radiation:
Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed
between the last dose and enrollment to the trial. Exceptions may be made for low dose,
non-myelosuppressive radiotherapy after consultation with NCIC CTG. Prior strontium is not
permitted.
- Laboratory Requirements (must be done within 7 days prior to randomization)
Hematology:
Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L
Biochemistry:
Serum creatinine ≤ 1.5 x ULN Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to
conditions such as Gilbert's disease) ALT and AST ≤ 1.5 x ULN Proteinuria <2g/24hrs (screen
using spot testing; if ≥ grade 2 repeat with mid-stream urine - if still ≥ grade 2 then
urine collection for 24 hours to confirm <2g/24hrs)
- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate.
Patients who cannot give informed consent (i.e. mentally incompetent patients, or those
physically incapacitated such as comatose patients) are not to be recruited into the study.
Patients competent but physically unable to sign the consent form may have the document
signed by their nearest relative or legal guardian. Each patient will be provided with a
full explanation of the study before consent is requested.
- Patients must be accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating centre. This implies there
must be reasonable geographical limits (for example: 2 hour's driving distance) placed
on patients being considered for this trial. Investigators must assure themselves that
the patients registered on this trial will be available for complete documentation of
the treatment, adverse events, response assessment and follow-up.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working
days of patient randomization.
Exclusion Criteria:
- Patients with a history of other malignancies, except for adequately treated
non-melanoma skin cancer or solid tumours curatively treated with no evidence of
disease for ≥ 3 years.(Please call NCIC CTG if any questions about the interpretation
of this criterion).
- Patients who are on immunosuppressive therapy or have known HIV infection or active
hepatitis B or C.
- Patients with active or uncontrolled infections, or with serious illnesses or medical
conditions which would not permit the patient to be managed according to the protocol.
- Patients are not eligible if they have a known hypersensitivity to the study drug(s)
or their components.
- Patients with history of central nervous system metastases or untreated spinal cord
compression.
- Patients who have had prior treatment with docetaxel for advanced/metastatic disease.
- Men who are not sterile unless they use an adequate method of birth control.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Docetaxel, Reolysin and PrednisoneDocetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.

Drug:Docetaxel and PrednisoneDocetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Discuss Prednisone

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